BOSTON–While the Food and Drug Administration (FDA) has released guidelines for the regulation of mobile health (mHealth) apps that act as medical devices or as accessories to medical devices, the vast majority of mHealth apps remain unregulated and unevaluated. In a Viewpoint article, "In Search of a Few Good Apps", published in JAMA on March 24, 214, co-authors, David Bates, MD and Adam Landman, MD of Brigham and Women's Hospital (BWH) and Adam Powell, PhD, president of Payer+Provider Syndicate, call for the creation of mHealth (mobile health) app review and certification organizations to evaluate apps that are not regulated by the government.
"This article gives health care providers, patients, policymakers and mHealth app developers a perspective on how the issue of determining which apps are most useful might be addressed," said Bates, who is Chief Quality Officer at BWH and chaired the Food and Drug Administration Safety and Innovation Act (FDASIA) Workgroup that made recommendations to the government about regulation of HIT and mobile apps. "Establishing an unbiased review and certification process is a key step in helping mHealth apps achieve their potential."
The concept for this Viewpoint article was conceived by Landman and Powell after discussing their mutual concern about the lack of oversight over the accuracy, quality, and security of mHealth apps at the BWH Hackathon, an event sponsored by BWH's Innovation Hub (iHub).
"Dr. Powell and I examined numerous mHealth apps and it was difficult to assess app credibility," said Landman, Chief Medical Information Officer for Health Information Innovation and Integration and an emergency medicine physician at BWH. "The currently available reviews of mHealth apps have largely focused on personal impressions, rather than evidence-based, unbiased assessments of clinical performance and data security. With more rigorous certification criteria and unbiased accrediting bodies, both clinicians and consumers could be more confident in their selection and use of mHealth apps."
In the article, authors describe the potential for multiple organizations to be created that could review and objectively certify mHealth apps for quality, accuracy, security and safety, similar to the role that Health On the Net Foundation (HON), a non-profit, non-governmental organization, plays in evaluating the quality of online medical content.
"People are increasingly turning to their smartphones for assistance in improving their health, but are having difficulty determining which apps are the securest and most effective. We hope that our article will instigate action that will enable clinicians and patients to make more effective use of mHealth apps," said Powell, lead author of the article. "We foresee a potential future in which physicians will be able to confidently prescribe apps to their patient, and will have the tools that they need to interpret the resulting data. The establishment of an unbiased app certification and review process will play a key role in getting us there."
Brigham and Women's Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 3.5 million annual patient visits, is the largest birthing center in New England and employs nearly 15,000 people. The Brigham's medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in patient care, quality improvement and patient safety initiatives, and its dedication to research, innovation, community engagement and educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, more than 1,000 physician-investigators and renowned biomedical scientists and faculty supported by nearly $650 million in funding. For the last 25 years, BWH ranked second in research funding from the National Institutes of Health (NIH) among independent hospitals. BWH continually pushes the boundaries of medicine, including building on its legacy in transplantation by performing a partial face transplant in 2009 and the nation's first full face transplant in 2011. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information, resources and to follow us on social media, please visit BWH's online newsroom.